Engineering Manager

What You Will Own: Program Leadership: Own the full NPI program from transfer through production launch — driving the integrated program plan, milestone tracking, risk management, and cross-functional alignment across engineering, quality, operations, and supply chain Customer Relationship: Serve as the primary technical point of contact for the customer during the NPI process — building trust through consistent communication, proactive risk escalation, and reliable delivery on commitments Process Validation: Lead IQ, OQ, and PQ execution in compliance with FDA and ISO 13485 requirements — ensuring the process is validated, documented, and ready for production before a single unit ships to the customer Cross-Functional Alignment: Drive alignment across engineering, quality, operations, supply chain, and global program management — ensuring all functions are engaged, accountable, and moving together toward the program milestones Team Leadership: Lead, develop, and inspire a team of NPI engineers — setting clear expectations, providing regular feedback, and building the technical capability of the team Risk Management: Identify, communicate, and mitigate program risks early — never letting a risk become a surprise. Escalate blockers proactively and drive resolution with urgency Production Readiness: Ensure the production line, operators, equipment, documentation, and quality controls are fully ready before production begins — no shortcuts, no surprises Continuous Improvement: Drive lessons learned after every program phase — building a stronger, faster, and more reliable NPI process with every program we complete What We Are Looking For: Experience and Education: Bachelor's degree in Engineering — Mechanical, Industrial, Biomedical, or related field required Eexperience in NPI, program management, or process engineering in a medical device manufacturing environment Direct experience leading IQ, OQ, and PQ validation in an FDA regulated and ISO 13485 environment Experience managing cross-functional teams and driving programs in a complex, fast-paced manufacturing environment Experience working directly with customers in a technical program management capacity PMP certification is a plus but not required Technical Skills: Strong understanding manufacturing processes — medical and catheter manufacturing experience is a significant plus Proficiency in program management tools — integrated program plans, milestone tracking, risk registers, and action logs Working knowledge of FDA regulations, ISO 13485, and GMP requirements Experience with PFMEA, control plans, and process validation documentation Ability to read and interpret engineering drawings, specifications, and technical documentation Leadership and Behavioral Competencies: Makes and meets commitments: When you commit to a milestone or a deliverable, you deliver. Your word matters and your team and your customers know it Drives with urgency: You move fast, you prioritize ruthlessly, and you do not wait to be told what to do next Communicates proactively: You surface risks early, you never let a problem become a surprise, and you communicate clearly and consistently with your team and your customers Solves root causes: You do not accept workarounds or band-aids when a real solution is possible. You dig until you find the root cause and you fix it Builds trust: With your team, with your customers, and with the broader organization. You are the person people count on when it matters most Develops people: You invest in your team, you give honest feedback, and you build the capability of the people around you One ATL mindset: You see yourself as part of a broader team — not just your program or your function. You support your colleagues and you show up as a partner to the full site Language: Fluent in Spanish and English — written and verbal. The ability to communicate effectively with both the local Costa Rica team and the global engineering and customer teams is essential